Novo Nordisk sinks 14% on disappointing drug news

MADRID (MarketWatch) — Shares of Novo Nordisk AS sank 14% in European trading on Monday. In a statement the prior day, the Danish drugmaker said the Danish drugmaker said the U.S. Food and Drug Administration declined to approve its new-drug applications for insulin Tresiba and a related product, Ryzodeg. The company said it received a Complete Response Letter from the FDA, which means an application can’t be approved in its current form. The FDA requested additional cardiovascular trial data, which Novo Nordisk does not expect to be able to provide during 2013. The FDA also said approvals for those drugs can’t be granted until violations cited in a Warning Letter, issued in Dec. 2012, are resolved. Novo Nordisk submitted those drugs for approval to the FDA in September 2011. The drugs are approved in Japan, the EU and Mexico. Novo Nordisk said it doesn’t see any significant impact from the FDA’s latest response on the company’s financial results in 2013.

Novo Nordisk sinks 14% on disappointing drug news

MADRID (MarketWatch) — Shares of Novo Nordisk AS sank 14% in European trading on Monday. In a statement the prior day, the Danish drugmaker said the Danish drugmaker said the U.S. Food and Drug Administration declined to approve its new-drug applications for insulin Tresiba and a related product, Ryzodeg. The company said it received a Complete Response Letter from the FDA, which means an application can’t be approved in its current form. The FDA requested additional cardiovascular trial data, which Novo Nordisk does not expect to be able to provide during 2013. The FDA also said approvals for those drugs can’t be granted until violations cited in a Warning Letter, issued in Dec. 2012, are resolved. Novo Nordisk submitted those drugs for approval to the FDA in September 2011. The drugs are approved in Japan, the EU and Mexico. Novo Nordisk said it doesn’t see any significant impact from the FDA’s latest response on the company’s financial results in 2013.